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InterSEPT: In-Tunnel SeptRx European PFO Trial

NCT01385670 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2011-06-30

No results posted yet for this study

Summary

The objective of this study is to determine the safety, performance, and effectiveness of the SeptRx IPO PFO Closure System in the treatment of Patent Foramen Ovale (PFO) in patients who are amenable to percutaneous closure of their PFO defects.

Conditions

  • Foramen Ovale, Patent
  • Heart Defects, Congenital
  • Heart Septal Defects

Interventions

DEVICE

Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)

Transcatheter PFO closure

Sponsors & Collaborators

  • SeptRx, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-06-30

Countries

  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01385670 on ClinicalTrials.gov